Politics

Unauthorized human experiments to be banned

The Executive Yuan approved a draft bill on research on human subjects June 3 that would require researchers to obtain the informed written consent of their study subjects.

The bill stipulates that researchers in seeking consent must first explain to the subjects the risks involved in the research, their rights and interests, as well as the purpose of the research. The research organizations would also be required to gain the approval of an ethics committee for the planned studies.

Violators would be subject to fines of between NT$100,000(US$3,125) and NT$1 million.

The Department of Health, which mapped out the draft bill, said it is aimed at promoting the development of scientific study concerning humans. It would also give legal status to policy guidelines on research on human subjects announced in July 2007.

The bill to guarantee the rights of study subjects is also in line with stipulations contained within the Indigenous Peoples Basic Act.

It states that coercion, enticement through promises of material gain, or other irregular methods should not be used in conducting research on human subjects.

As for research on fetuses or cadavers, the consent of the closest relatives must first be obtained, with violators to be fined between NT$50,000 and NT$500,000.

In addition, the draft bill prohibits the use of prisoners as research subjects, with the restriction being waived only in instances when they cannot be replaced with other subjects.

Human rights groups said formulation of the draft bill was accelerated by the recent case involving a research team led by Ko Ying-chin, vice president of Kaohsiung Medical University. Ko applied for patents in the United States for gout research findings allegedly obtained by using blood samples from aboriginal citizens without gaining their prior consent.

This case gave rise to a storm of controversy regarding medical ethics. The National Health Research Institutes’ subsequent decision to cancel the patent applications was heralded as a “great step forward for human rights” by the rights activist groups. (SB)